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Medium risk Drugs & MedicationsClass II

Elekta, Inc. Recall

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Updated December 10, 2025

Elekta, Inc. is recalling MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO). Hazard: Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice

Is the Elekta, Inc. recalled? Yes. This product was recalled by FDA on December 10, 2025. Details below.

What is recalled

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice

Brands affected

Elekta, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1078-2026
Classification
Class II
Recalled
December 10, 2025
Read the official notice

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